Zdrowie i gospodarka · 05/11/2018

FDA Releases Guidance on Unique Device Identification Policy for Class I and Unclassified Devices

The Food and Drug Administration (FDA) has announced the availability of a new guidance document outlining its policy regarding compliance dates for class I and unclassified devices, as well as certain devices requiring direct marking. The policy, which is effective immediately, provides relief from certain requirements until September 24, 2020, and September 24, 2022, respectively.